MONOPREP PAP TEST
FDA premarket approval P040052/S004 · decided 2007-08-31
Approval details
- PMA number
- P040052
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MONOPREP PAP TEST
- Generic name
- Processor, cervical cytology slide, automated
- Applicant
- Hologic, Inc.
- Date received
- 2007-07-27
- Decision date
- 2007-08-31
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- MKQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- APPROVAL FOR USE OF REFLECTIVE WHITE LABEL STOCK (PN 12358) ON ALL MONOPREP VIALS, INCLUDING THE MONOPREP PAP TEST VIAL AND THE REPROCESSING VIAL.
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